FDA.reportPublic FDA data

Omeprazole

Product NDC
55111-644
11-digit product format
551110644
Labeler code
55111
Product ID
55111-644_8ebe8fd4-472a-4fb0-3a62-4bb87eb0381d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55111-644-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10034
55111-644-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50034
55111-644-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100034
55111-644-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3034
55111-644-77Omeprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE134
55111-644-77Omeprazole7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE734

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-644OMEPRAZOLE CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES LIMITED]30Current NDC, Legacy NDC, 6 package rows20240616_603d2d06-c5e8-4378-a422-8dca1a410af7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN96104ea6-c08f-40b5-83f5-d840b317f1fd36
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD96104ea6-c08f-40b5-83f5-d840b317f1fd36
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY96104ea6-c08f-40b5-83f5-d840b317f1fd36
199119omeprazole 10 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
200329omeprazole 40 MG Delayed Release Oral CapsulePSN603d2d06-c5e8-4378-a422-8dca1a410af734
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD603d2d06-c5e8-4378-a422-8dca1a410af734
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY603d2d06-c5e8-4378-a422-8dca1a410af734
198051omeprazole 20 MG Delayed Release Oral CapsulePSN63b3982a-b541-4b0d-99d4-93a673e57d467
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD63b3982a-b541-4b0d-99d4-93a673e57d467
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY63b3982a-b541-4b0d-99d4-93a673e57d467
198051omeprazole 20 MG Delayed Release Oral CapsulePSN28515ff8-379d-5356-e063-6394a90af3f35
198051omeprazole 20 MG Delayed Release Oral CapsulePSN205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD28515ff8-379d-5356-e063-6394a90af3f35
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY28515ff8-379d-5356-e063-6394a90af3f35
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG Delayed Release Oral CapsulePSN2fd1acb8-12dc-70b7-e063-6394a90a03993
198051omeprazole 20 MG Delayed Release Oral CapsulePSN59d8be3f-ba13-4897-9ceb-f8ac6ccc16243
198051omeprazole 20 MG Delayed Release Oral CapsulePSN4c0cf466-f9e8-390e-e063-6294a90a2ed83
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD2fd1acb8-12dc-70b7-e063-6394a90a03993
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD59d8be3f-ba13-4897-9ceb-f8ac6ccc16243
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD4c0cf466-f9e8-390e-e063-6294a90a2ed83
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY4c0cf466-f9e8-390e-e063-6294a90a2ed83
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY2fd1acb8-12dc-70b7-e063-6394a90a03993
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY59d8be3f-ba13-4897-9ceb-f8ac6ccc16243
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3724b8f7-52ff-a5f8-e063-6294a90acf202
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3724b8f7-52ff-a5f8-e063-6294a90acf202
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3724b8f7-52ff-a5f8-e063-6294a90acf202
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc8f2e604-74fa-4205-b41f-32401e2dc59e1
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa806da8c-5f84-454d-966c-da1c48710f801
198051omeprazole 20 MG Delayed Release Oral CapsulePSN2cdc6809-3b1b-046a-e063-6394a90ae02a1
198051omeprazole 20 MG Delayed Release Oral CapsulePSN30955530-56d2-174d-e063-6294a90a413c1
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3b19d724-821b-61dc-e063-6294a90aa4d31
198051omeprazole 20 MG Delayed Release Oral CapsulePSN487ff32f-943e-458b-b898-bd7b0290cc491
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD30955530-56d2-174d-e063-6294a90a413c1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3b19d724-821b-61dc-e063-6294a90aa4d31
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD487ff32f-943e-458b-b898-bd7b0290cc491
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc8f2e604-74fa-4205-b41f-32401e2dc59e1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD2cdc6809-3b1b-046a-e063-6394a90ae02a1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa806da8c-5f84-454d-966c-da1c48710f801
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc8f2e604-74fa-4205-b41f-32401e2dc59e1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY30955530-56d2-174d-e063-6294a90a413c1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa806da8c-5f84-454d-966c-da1c48710f801
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY2cdc6809-3b1b-046a-e063-6394a90ae02a1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3b19d724-821b-61dc-e063-6294a90aa4d31
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY487ff32f-943e-458b-b898-bd7b0290cc491

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-644-0155111064401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-01) 2014-03-010000-00-00NoNoCurrent
55111-644-0555111064405500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-05) 2014-03-010000-00-00NoNoCurrent
55111-644-10551110644101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-10) 2014-03-010000-00-00NoNoCurrent
55111-644-305511106443030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (55111-644-30) 2014-03-010000-00-00NoNoCurrent
55111-644-77551110644771 BLISTER PACK in 1 CARTON (55111-644-77) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2014-03-010000-00-00NoNoCurrent